Injection of Freshly Collected Autologous Adipose Tissue Additional to Bascom's Cleft Lift Surgery

NCT05830734 | Recruiting DMC

• 1 other identifier: RCTBCLAFI2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In brief, the right management of complex or recurrent pilonidal disease (PD) is still controversial. In our institution we treat these conditions with Bascom's cleft lift surgery. Though this approach for most parts is beneficial, a large proportion of patients will suffer from prolonged post operative healing. We have published some positive results on treating non-healing postoperative wounds after cleft lift surgery with autologous fatty cell transplantation. The overall aim of the project is to investigate whether the addition of autologous fat cell transplantation in the surgical treatment of PD reduces the incidence of patients with prolonged postoperative healing. In a double-blinded randomized controlled clinical trial, we will investigate the effect of injections of freshly harvested autologous fatty cells in addition to Bascom's cleft lift operation versus Bascom's cleft lift operation alone.

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (2)

• healing

  Healing of the pilonidal lesion (max 1 defect ≤5mm, no undermining)

  4 weeks

• healing

  Healing of the pilonidal lesion (max 1 defect ≤5mm, no undermining)

  12 weeks

Secondary Outcomes (7)

• Symptom development

  pre-operatively, at 4 weeks, 12 weeks and 12 months

• postoperative pain

  first 14 postoperative days

• complications

  12 weeks

• Time to healing

  upto 12 months

• recurrence

  12 months

Study Arms (2)

BCL surgery with fatty cell injection arm

EXPERIMENTAL

Patients will undergo BCL surgery and additionally have to small incisions made in the lumbar region from which 80 ml of fatty cells are harvested. After harvest local anesthetics are injected bilaterally and a compression bandage applied. The fatty cells are injected into the surgical wound before closure. All wounds are lateralized and close with a suction drain removed after 3 days

Other: injection of freshly collected adipose cells; Procedure: Bascoms Cleft lift procedure

BCL surgery alone arm

SHAM COMPARATOR

Patients will undergo BCL surgery. Additionally two small incisions are made in the lumbar region, local anesthetics are injected bilaterally and a compression bandage applied. All wounds are lateralized and close with a suction drain removed after 3 days

Procedure: Bascoms Cleft lift procedure

Interventions

injection of freshly collected adipose cells OTHER

A small incision is made bilaterally in the lumbar region. 2-300 ml of Ringer's acetate with 1 mg of added adrenaline is introduced with an infusion cannula fan-shaped into the subcutaneous adipose tissue on each side of the region. Adipose tissue is harvested for a total of approx. 80 ml. 20 ml Bupivacaine 5 mg/ml is distributed on each side of the lower back. The incisions are then closed with Steri-Strips and a compressive dressing is applied to reduce the risk of hematoma. The harvested adipose tissue then centrifuged in bulks of four at 1000 rpm. minute for 3 minutes. The liquid fraction is discarded. Using a three-way tap system, the adipose tissue is microfragmented between two 10 ml syringes by moving the contents back and forth at least 20 times. The adipose tissue is then distributed in 2 ml syringes for injection. A total of between 25 and 55 ml of usable adipose tissue will be harvested.

BCL surgery with fatty cell injection arm

Bascoms Cleft lift procedure PROCEDURE

The procedure is carried out according to standardized principles previously decribed by Drs. John and Tom Bascom

BCL surgery alone arm; BCL surgery with fatty cell injection arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced pilonidal disease with indication for surgery with Bascom's cleft lift surgery due to either
• Primary extensive manifestation where minimally invasive surgery is not possible
• Lack of healing after previous surgery (\> 2 months)
• Recurrence after previous elective surgery
• Informed and written consent, as well as consent for follow-up.
• Danish speaking/reading and thus able to understand Danish patient information, questionnaires and the pleje.net system.

You may not qualify if:

• Acute infection in pilonidal disease
• Pregnancy
• BMI \<20 and \>35
• Smokers (stop smoking at least 6 weeks before and after the operation)
• Insulin-dependent diabetes
• Age \<15 years
• Bilateral extension not suitable for BCL surgery

Sponsors & Collaborators

• University of Aarhus: lead
• Region Zealand: collaborator

Study Sites (1)

Regions Hospitalet Randers

Randers, Jylland, 8930, Denmark

RECRUITING

Related Publications (23)

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• Luedi MM, Schober P, Stauffer VK, Diekmann M, Doll D. Global Gender Differences in Pilonidal Sinus Disease: A Random-Effects Meta-Analysis. World J Surg. 2020 Nov;44(11):3702-3709. doi: 10.1007/s00268-020-05702-z. Epub 2020 Jul 17.

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• Mostafaei S, Norooznezhad F, Mohammadi S, Norooznezhad AH. Effectiveness of platelet-rich plasma therapy in wound healing of pilonidal sinus surgery: A comprehensive systematic review and meta-analysis. Wound Repair Regen. 2017 Nov;25(6):1002-1007. doi: 10.1111/wrr.12597. Epub 2018 Feb 7.

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• Mohamadi S, Norooznezhad AH, Mostafaei S, Nikbakht M, Nassiri S, Safar H, Moghaddam KA, Ghavamzadeh A, Kazemnejad A. A randomized controlled trial of effectiveness of platelet-rich plasma gel and regular dressing on wound healing time in pilonidal sinus surgery: Role of different affecting factors. Biomed J. 2019 Dec;42(6):403-410. doi: 10.1016/j.bj.2019.05.002. Epub 2019 Dec 10.

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Study Officials

• susanne Haas, MD PHD

  University of Aarhus

  STUDY CHAIR

Central Study Contacts

Ida Faurschou, MD

CONTACT

28707759; idafau@rm.dk

susanne Haas, MD PHD

CONTACT

31565246; susahaas@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will all receive BCL surgery and all have two small incisions in in the lumbar region with local anesthetic injection and compression bandages. Only the intervention group with have fatty cells harvested and injected in the surgical wound. The out comes assessor is blinded to which treatment has been given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, assosciate professor

Model Details: Double blinded randomized controlled trial

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: April 26, 2023
• Study Start: January 4, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)